Senior Scientist, Process Analytics
Location: Waltham, MA
Palleon Pharmaceuticals is seeking a talented individual to fill the position of Sr. Scientist, Process Analytics. S/he will report to the VP of CMC and will play a key role in using state-of-the-art analytical techniques to support process development, including cell culture, purification, and formulation development. S/he will also contribute to protein biochemical/biophysical characterizations, material comparability studies, stability studies, technology transfer, and manufacturing process support. S/he must have a strong background in analytical assay development, protein biochemistry and process characterization, and a good understanding of biotherapeutic product development in general.
- Develop analytical methods for protein product characterization including purity, quantity, enzymatic activity, biochemical and biophysical properties, and structural/functional analysis.
- Design and execute analytical tests for raw materials identification, process intermediates characterization, and process impurity analysis.
- Investigate and mitigate protein instability during the manufacturing process, and conduct material compatibility and stability studies under real-time or accelerated conditions.
- Closely interact with discovery, development, and CRO for process development, technology transfer, and process implementation.
- Provide technical support for GMP and/or non-GMP manufacturing activities, including deviation investigation and process change.
- Write and review study protocols, technology transfer documents, and manufacturing batch records, and present study data to both internal and external audiences.
- BS/MS degree in relevant scientific discipline with 10+ years of industry experience, or PhD with 3 – 7 years of industry experience.
- Strong scientific expertise and hands-on experience in protein characterization using different techniques, including HPLC, DSC, CE-SDS, cIEF, CD, DLS, Raman, viscometer, and sub-visible particle measurement.
- Ability to work independently in assay development and qualification, with in-depth knowledge of protein stability/degradation.
- A good team player who interacts well with other team members and external partners.
- Strong technical writing and communication skills, with the ability to contribute to the authoring and submission of IND and other regulatory documents.
- Previous experience in process development for biotherapeutics, with knowledge across technical domains, including cell culture, chromatography, and formulation. Working knowledge of CMP compliance.
- Experience in protein/function characterization and LC-MS is preferred.
Who We Are:
Palleon Pharmaceuticals is the leading biotechnology company developing drugs that target glycan-mediated immune regulation to treat cancer and inflammatory diseases. The company’s proprietary platforms integrate technologies and insights from global scientific leaders in the glyco-immunology field to overcome historical scientific hurdles and create novel therapeutics for devastating diseases characterized by immune system dysfunction. Palleon’s lead program in oncology, an enzymatic sialoglycan degrader for T cell exhaustion in cancer, is expected to enter clinical testing in 2021. The company has several other drug discovery programs underway in disease areas where glycan-mediated immune regulation plays a role, including inflammatory diseases such as autoimmunity and fibrosis. Palleon was launched in 2015. The company recently raised a $100 million Series B financing from leading investors Matrix Capital Management, Surveyor Capital (a Citadel company), SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures and AbbVie Ventures. Learn more at www.palleonpharma.com.